Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Mandatory Active Choice | The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so. Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form. | None | None | 0 | 0 | 0 | 642 | View |
| Control | Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task. | None | None | 0 | 0 | 0 | 637 | View |